ANDA 062212

GLAXOSMITHKLINE

FDA Drug Application

Application #062212

Application Sponsors

ANDA 062212

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	CAPSULE;ORAL	EQ 250MG BASE	0	TOTACILLIN	AMPICILLIN/AMPICILLIN TRIHYDRATE
002	CAPSULE;ORAL	EQ 500MG BASE	0	TOTACILLIN	AMPICILLIN/AMPICILLIN TRIHYDRATE

FDA Submissions

	ORIG	1	AP	1979-08-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-04-20

Submissions Property Types

SUPPL

5

Null

0

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62212
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOTACILLIN","activeIngredients":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","strength":"EQ 250MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TOTACILLIN","activeIngredients":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","strength":"EQ 500MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOTACILLIN","submission":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","actionType":"EQ 250MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TOTACILLIN","submission":"AMPICILLIN\/AMPICILLIN TRIHYDRATE","actionType":"EQ 500MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)